NCT03057808

Brief Summary

The purpose of this study is to enroll approximately 450 subjects to see if a behavioral weight management program is successful in helping TRICARE beneficiaries who are pregnant or post-partum to manage their weight during and after their pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2022

Completed
7 months until next milestone

Results Posted

Study results publicly available

December 23, 2022

Completed
Last Updated

December 23, 2022

Status Verified

July 1, 2022

Enrollment Period

4.8 years

First QC Date

January 3, 2017

Results QC Date

July 14, 2022

Last Update Submit

December 2, 2022

Conditions

Weight GainWeight Loss

Keywords

PregnancyPostpartum

Outcome Measures

Primary Outcomes (1)

  • Changes in the Mother's Body Weight Pre and Post Pregnancy

    At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While Investigators obtain the mother's weight at baseline, there will also be a self reported pregravid weight (before the last menstrual period).

    Baseline to 6 months postpartum

Secondary Outcomes (8)

  • Maternal and Fetal Conditions During Pregnancy

    Baseline (13 weeks gestational to delivery)

  • Birth Weight of Infant

    Delivery

  • Length of Infant

    Delivery

  • Waist Circumference on Fitness Test Scores

    Baseline and 12 months postpartum

  • Number of Push Ups on Fitness Test Scores

    Baseline and 12 months postpartum

  • +3 more secondary outcomes

Study Arms (3)

Gestational weight gain intervention (GWG-only)

EXPERIMENTAL

The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child.

Behavioral: Gestational weight gain intervention

Postpartum weight loss intervention (PPWL-only)

EXPERIMENTAL

The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum.

Behavioral: Postpartum weight loss intervention

Combined

EXPERIMENTAL

During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group.

Behavioral: Gestational weight gain interventionBehavioral: Postpartum weight loss intervention

Interventions

Gestational weight gain interventionBEHAVIORAL

This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.

Also known as: GWG-only
CombinedGestational weight gain intervention (GWG-only)
Postpartum weight loss interventionBEHAVIORAL

The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.

Also known as: PPWL-only
CombinedPostpartum weight loss intervention (PPWL-only)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be active duty military, dependents or retired with TRICARE benefits
  • Participants must be less than 12 weeks gestation upon recruitment (based on the date of their last menstrual period and then confirmed by their physician at their first prenatal visit, which typically occurs at 6-8 weeks gestation at WHASC and SAMMC)
  • Participants also must be within the normal, overweight, or obese BMI ranges
  • Are generally in good health
  • Currently not smoking more than 5 cigarettes per day at the time of conception

You may not qualify if:

  • Expecting multiple babies (e.g. twins)
  • Diabetic
  • Not interested in participating in a program for 21 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Antonio Military Medical Center Obstetrics Clinic (SAMMC)

San Antonio, Texas, 78219, United States

Location

Wilford Hall Ambulatory Surgical Center

San Antonio, Texas, 78236, United States

Location

Related Publications (4)

  • Solomon E, McPhail A, Bursac Z, Little MA, Talcott GW, Krukowski RA. Provider advice, pregnant persons' expectations, and actual gestational weight gain among United States military health care beneficiaries: a secondary analysis of a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Nov 25;24(1):785. doi: 10.1186/s12884-024-06987-x.

    PMID: 39587506DERIVED

  • Perez-Munoz A, Hare ME, Andres A, Klesges RC, Wayne Talcott G, Little MA, Waters TM, Harvey JR, Bursac Z, Krukowski RA. A Postpartum Weight Loss-focused Stepped-care Intervention in a Military Population: A Randomized Controlled Trial. Ann Behav Med. 2023 Sep 13;57(10):836-845. doi: 10.1093/abm/kaad014.

    PMID: 37061829DERIVED

  • Pebley K, Farage G, Hare ME, Bursac Z, Andres A, Chowdhury SMR, Talcott GW, Krukowski RA. Changes in self-reported and accelerometer-measured physical activity among pregnant TRICARE Beneficiaries. BMC Public Health. 2022 Nov 7;22(1):2029. doi: 10.1186/s12889-022-14457-2.

    PMID: 36336697DERIVED

  • Estevez Burns R, Hare ME, Andres A, Klesges RC, Talcott GW, LeRoy K, Little MA, Hyrshko-Mullen A, Waters TM, Harvey JR, Bursac Z, Krukowski RA. An interim analysis of a gestational weight gain intervention in military personnel and other TRICARE beneficiaries. Obesity (Silver Spring). 2022 Oct;30(10):1951-1962. doi: 10.1002/oby.23523. Epub 2022 Aug 30.

    PMID: 36041980DERIVED

MeSH Terms

Conditions

Weight GainWeight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Rebecca Krukowski
Organization
University of Virginia
wae4mq@virginia.edu
4349245303

Study Officials

  • Rebecca Krukowski, PhD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

February 20, 2017

Study Start

February 6, 2017

Primary Completion

November 10, 2021

Study Completion

May 26, 2022

Last Updated

December 23, 2022

Results First Posted

December 23, 2022

Record last verified: 2022-07

Locations

US(2)